Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06747338

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Led by Shanghai JMT-Bio Inc. · Updated on 2025-04-24

520

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.

CONDITIONS

Official Title

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age 18 years or older
  • Confirmed primary invasive breast cancer, early (T2-3, N0-1, M0) or locally advanced stage (T2-3, N2-3, M0; T4, any N, M0)
  • ECOG performance status 0 or 1
  • HER2 positive status confirmed by IHC or ISH
  • Agree to have breast cancer surgery at study center after neoadjuvant therapy
  • Adequate organ and bone marrow function, no recent blood transfusions or growth factors
  • Women of childbearing potential and male partners agree to use effective contraception during treatment and for specified months after last dose
Not Eligible

You will not qualify if you...

  • Inflammatory or bilateral breast cancer
  • History of other cancers within 3 years except certain skin or cervical cancers
  • Contraindications for breast cancer surgery
  • Prior lumpectomy or lymph node dissection before randomization except diagnostic biopsy
  • Previous systemic chemotherapy, endocrine therapy, anti-HER2 therapy, or local radiotherapy for breast cancer
  • Allergies or sensitivity to study medications or their ingredients
  • Known allergies or contraindications to glucocorticoids
  • Congenital or acquired immune deficiency (e.g., HIV)
  • Serious heart or cardiovascular conditions
  • Serious infections requiring intravenous antimicrobial treatment within 14 days before randomization
  • Major organ surgery within 28 days before randomization and not fully recovered
  • Use of strong CYP3A4 inhibitors or inducers within 14 days before randomization
  • Participation in other clinical trials within 4 weeks before randomization except non-interventional trials
  • Pregnant or breastfeeding
  • Other conditions interfering with study participation or affecting study results, including neurological, mental illness, substance abuse, or clinically significant diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinical Trials Information Group

Shanghai, China

Actively Recruiting

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Research Team

C

Clinical Trials Information Group officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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